Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia

Not Recruiting

Trial ID: NCT00671034


This randomized clinical trial is studying giving calaspargase pegol together with combination chemotherapy to see how well it works compared with giving pegaspargase together with combination chemotherapy in treating younger patients with newly diagnosed high-risk acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

Official Title

A Pilot Study of Intravenous EZN-2285 (SC-PEG E. Coli L-asparaginase) or Intravenous Oncaspar® in the Treatment of Patients With High-Risk Acute Lymphoblastic Leukemia (ALL)

Stanford Investigator(s)


Inclusion Criteria:

   - Patients must be eligible for and enrolled on AALL08B1 or the successor classification

   - Patients must have newly diagnosed high-risk B lymphoblastic leukemia (World Health
   Organization [WHO] 2008 classification) (also termed B-precursor acute lymphoblastic

   - White blood cell (WBC) >= 50,000/μL for patients age 1-9 OR any WBC count for patients
   age 10-30 or for patients treated with prior steroids

   - Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids
   and intrathecal cytarabine; intrathecal chemotherapy with cytarabine is allowed prior
   to registration for patient convenience; this is usually done at the time of the
   diagnostic bone marrow or venous line placement to avoid a second lumbar puncture;
   (Note: the CNS status must be determined based on a sample obtained prior to
   administration of any systemic or intrathecal chemotherapy, except for steroid
   pretreatment) systemic chemotherapy must begin within 72 hours of this intrathecal

   - Patients receiving prior steroid therapy are eligible for this study; the dose and
   duration of previous steroid therapy should be carefully documented

   - Pregnancy tests with a negative result must be obtained in all post-menarchal females

   - Lactating females must agree that they will not breastfeed a child while on this study

Exclusion Criteria:

   - Patients with Down syndrome are excluded from this study

   - Patients with testicular leukemia at diagnosis are excluded from this study

   - Pregnant female patients are excluded from this study


radiation: radiation therapy

drug: cyclophosphamide

drug: cytarabine

drug: daunorubicin hydrochloride

drug: dexamethasone

drug: doxorubicin hydrochloride

drug: methotrexate

drug: pegaspargase

drug: prednisone

drug: vincristine sulfate

drug: thioguanine

other: laboratory biomarker analysis

other: pharmacological study

drug: Calaspargase Pegol-mknl

drug: Mercaptopurine

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs

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